Sunday, June 17, 2012

Price is not justification for Using a Compounded Product

An article in Veterinary Practice News written by Lou Anne Epperley, DVM appearing here discusses why price is not a justification for using compounded products.

That articles states in part: 

No wonder some veterinarians want to believe there’s a cheaper way to achieve the desired result promised by federal Food and Drug Administration-approved veterinary drugs.
For any given scenario, you might luck out with a compounded home remedy. But there’s a substantial case to be made for advocating the treatments bearing the government label.
“What’s happening in our profession is that veterinarians are compounding as a way to get a cheaper product,” said Dawn Merton Boothe, DVM, MS, Ph.D., professor and director of clinical pharmacology at Auburn University in Alabama. “Veterinarians are legally empowered to use drugs extra-label and compounded drugs as well. But that does not absolve them from civil liability. Cost is not a justification for using a compounded product.”
Compounding doesn’t have to be a dirty word. The FDA Extra-label Drug Use regulations define compounding as a “customized manipulation” of an approved drug or drugs by a veterinarian or pharmacist to meet the needs of a particular patient. When you mix two injectable drugs, make a paste or suspension from crushed tablets, or add flavoring, you’re legally compounding. It is illegal, however, to mix homemade drugs from bulk or raw active ingredients.
“Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug,” says a brochure published jointly by the Animal Health Institute, the American Veterinary Medical Association and the American Veterinary Distributors Association.


Questions to ask include:
"Practitioners should ensure that the pharmacy they are using is, first, licensed in its respective state and, second, has quality standards in place to satisfy your exacting standards,” Sheehan said. “To that end, we encourage practitioners to ask those hard questions. To know the country of origin for bulk powders is not nearly as meaningful as knowing what that pharmacy does with that powder to ensure its potency. Ask about the pharmacy’s quality program before you align with them.”

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